Important DF/HCC Policy Exceptions and Clarifications Related to COVID-19

Relaxed Eligibility Checklist Requirements

DF/HCC leadership has approved a blanket and temporary policy exception starting immediately and continuing through April 30, 2020. If  an appropriately qualified member of the study team is not available to complete and sign the eligibility checklist, it can be acknowledged and approved via email. This email documentation must be filed with the eligibility checklist in the research chart. 

Under this temporary exception, DF/HCC will no longer require the checklist itself to be signed prior to registration.

In accordance with  REGIST-100, if the screening staff approving eligibility is a  physician investigator or physician subinvestigator, the checklist plus email approval together may be used as source documentation.

A note-to-file documenting the policy exception is posted to the DF/HCC website 

Relaxed Delegation of Authority Requirements

Individuals providing coverage for standard of care procedures or administrative tasks do not generally need to be listed on the delegation of authority. However, any individual performing significant trial-related duties or performing safety related tasks must be appropriately qualified and delegated these responsibilities by the PI. 

Due to the requirement to decrease and consolidate clinical staff that are onsite, there is an increased need for a limited number of staff to cover a broader range of research activities conducted by staff (MDs, NPs, PAs, Research Nurses, Coordinators, etc.) that are not listed on the study. We would expect this will typically be in situations where the participant is being seen due to an adverse event but may include other visits or tasks when necessary in order to fulfill clinical oversight during periods of reduced staffing. 

DF/HCC leadership has approved a blanket and temporary policy exception starting immediately and continuing through April 30, 2020. Since these are covering situations, these individuals do not need to be added to the delegation of authority log if the appropriate study staff remain accessible remotely and will be able to fulfill research oversight. Communication between the covering staff and study team will be appropriately documented and maintained in the research subject file.

A note-to-file documenting the policy exception is posted to the DF/HCC website 

Protocol Deviations/Violations related to COVID-19

Deviations and violations that have the potential to impact patient safety or trial integrity, including eligibility exceptions, require IRB review. The DFCI IRB will not approve blanket requests to deviate from a protocol. Deviation requests must be specific to a single patient and detail the event and plan for that patient. Sponsor approval is required as part of the submission.

For deviations and violations related to COVID-19, please clearly indicate that the event is related to COVID-19 in the submission. For these events, three or more minor violations of the same type will not require automatic reporting of a major violation to the DFCI IRB. In addition, the DFCI IRB will consider multiple major deviations related to COVID-19 of the same type on a protocol without automatically requiring an amendment. 

However, the principal investigator and treating investigator must consider whether multiple requests, in aggregate, compromises patient safety and/or trial integrity. Investigators must include in the event submission their assessment of the risk/benefit to keeping a participant on trial when they are unable to obtain protocol-required treatment or procedures. If a participant is entirely unable to access care or therapy that is mandated by the trial, it may not be appropriate to continue the participant on study. This is particularly applicable if it is unknown when the participant will regain access to care and with requests to miss or delay multiple visits that may significantly impact safety, efficacy, or trial integrity.

Sponsor-issued COVID-19 Letters

We have received a number of questions regarding how to submit sponsor clarification letters issued in response to the COVID-19 pandemic.

Most of these letters do not change the protocol, but rather provide information and clarifications to research staff. These can be distributed internally in the research group as needed. The DFCI IRB won't be approving or posting these types of letters.

If there is a change the protocol requirements or procedures, the revised study documents must be submitted as an amendment along with any relevant sponsor correspondence. However, the sponsor correspondence alone will not be approved and posted.

Reminder: 1572 Updates

Per DF/HCC policy RCO-203, the Form FDA 1572 does not need to be revised to add a laboratory or testing facility that is used infrequently or to obtain standard of care results. If revisions to the FDA 1572 are required, they may be batched for periodic updates. For example, new subinvestigators are not required to be listed on the FDA 1572 prior to participating in the research but may be added with a future update.